Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

NCT02930239 | Unknown Phase 2

• 1 other identifier: dnr 2016/25-31
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament

Keywords

ACL-reconstruction; Gait rehabilitation; Anti Gravity treadmill; ACL-rehabilitation

Outcome Measures

Primary Outcomes (1)

• 3 dimensional gait analysis

  A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg

  5 weeks post-surgery

Secondary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score

  5 weeks post-surgery

• International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)

  12 weeks post-surgery

• 3 dimensional gait analysis

  12 weeks post-surgery

Study Arms (2)

Gait rehabilitation

EXPERIMENTAL

Will perform 2 weeks of gait rehabilitation using the anti gravity treadmill. Intervention will start 2 weeks post-surgery. This rehabilitation will be performed simultaneously as the patient receives the standardized rehabilitation at Linkoping University Hospital.

Other: Gait rehabilitating with reduced bodyweight; Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital

Control group

ACTIVE COMPARATOR

Will only receive the standardized rehabilitation at Linkoping University Hospital.

Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital

Interventions

Gait rehabilitating with reduced bodyweight OTHER

Patients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery.

Gait rehabilitation

Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital OTHER

Exercises for increased movement and circulation performed on a daily basis.

Control group; Gait rehabilitation

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery

You may not qualify if:

• Previous Anterior cruciate ligament injury
• Other knee injury with restrictions that could interfere with rehabilitation
• Other injury or disease that could interfere with rehabilitation
• Inability to understand the information

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoping University

Linköping, Östergötland County, 58183, Sweden

RECRUITING

Study Officials

• Joanna Kvist, Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: October 12, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2018
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)